(323 days)
The eCO2 Plus Laser System with fractionated handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
The eCO2 Plus Laser System using the non-fractionated handpieces (F100, F50, and Zoom) is also indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery.
The DENTA III Laser System using the non-fractionated handpieces (F100, F50, and Zoom) is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional biopsy, incision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia: partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening.
The DENTA III+ Laser System using fractionated handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
The DENTA III+ Laser System using non-fractionated handpieces (F100, F50, and Zoom) is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional bionsy, incision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia; partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening.
The SP III Laser System using the non-fractionated handpieces (F100, F50, and Zoom) is indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery.
The eCO2 Plus, SP III, DENTA III and DENTA III+ Laser Systems utilize a CO2 RF module to generate a laser beam with a wavelength of 10.6 um and use different handpiece for different indications for use. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece. The Laser Systems are supplied with different handpieces depending upon the device configuration.
The provided 510(k) summary for the Lutronic Corporation eCO2 Plus, DENTA III, and SP III Laser Systems explicitly states:
"6. Performance Data: None presented."
Therefore, based on the provided document, the following information cannot be extracted:
- Table of acceptance criteria and reported device performance: No performance data or acceptance criteria are presented.
- Sample size used for the test set and data provenance: No test studies were described.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no test studies were described.
- Adjudication method for the test set: Not applicable as no test studies were described.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: No such study was mentioned.
- Standalone (algorithm only without human-in-the-loop performance) study: This device is a laser system, not an AI algorithm, so this is not applicable. Even if it were, no performance data is presented anyway.
- Type of ground truth used: Not applicable as no test studies were described.
- Sample size for the training set: This device is a laser system and does not involve a training set in the context of machine learning.
- How the ground truth for the training set was established: Not applicable as this device is a laser system and does not involve a training set.
The submission focuses solely on demonstrating substantial equivalence to predicate devices based on device description and intended use, rather than presenting novel performance data.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.